Zainab Assy

30 Chapter 2 So far, xerostomia questionnaires were aimed to quantify the overall feeling of mouth dryness and not the perceived xerostomia at different intraoral locations. Therefore, the purpose of this study is to evaluate a recently developed questionnaire, Regional Oral Dryness Inventory (RODI), which quantifies the severity of dryness at various locations in the mouth. MATERIALS AND METHODS Study design A retrospective case report study was designed. Data were collected from patients older than 18 years, who visited the saliva clinic for Special Care Dentistry in Amsterdam. These patients were referred to the saliva clinic by dentists, general physicians, and medical specialists between January 2014 and April 2019. All the patients included in this study had saliva-related and/ or dry-mouth complaints. The Ethics Review Committee of the Academic Centre for Dentistry Amsterdam (ACTA) confirmed that the Medical Research Involving Human Subjects Act (WMO) does not apply to this study (protocol number 201910). The reporting of this study conforms to the STROBE statement [25]. All the questionnaires and clinical parameters have been collected and interpreted by a single practitioner (DHJJ). A standardized protocol is used for this process, which takes approximately 45 min. All the procedures described in the present study are part of the regular patient care routine in the saliva clinic. Data collectionmethods The relevant data were extracted by one abstractor (EM) from the electronic health record systemOase Dental (VST Software B.V., Haarlem, The Netherlands). Patients were included when most of the relevant data were present in the record of the patient. The extracted data were registered pseudonymized in a Microsoft Excel under a code number so that the data can no longer be traced back to the patients. The following clinical data were retrieved: gender, age, the Xerostomia Inventory (XI) score, Clinical Oral Dryness Score (CODS), scores on the newly developed Regional Oral Dryness Inventory, and the secretion rates of unstimulated whole saliva (UWS), chewing-stimulated whole saliva (CH-SWS), and citric acid–stimulated whole saliva (A-SWS). Random checks were done after data entry, by two researchers (EM and ZA), to verify correct transfer of data from the medical record to the case reports. This was performed according to the 100-20 rule in which 100% of the data is

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